Even as the government is busy modifying regulations for the pharmaceutical industry in India to improve the quality and safety of medicines, the excipients industry which has much to do with the quality and shelf life of drugs still remains an unregulated sector in the country.

Only a minimum number of excipients, the inactive ingredients used in medicines to keep the drug in shape and mask the taste, are covered by the Indian Pharmacopoeia at present. These monographs, which ranges around 400 to 500 against a total of nearly 4000 excipients all over the world, consists only the basic products from sources like starch and lactos.

"Currently, there is no such regulation or audit applicable on the excipients industry in India. A regulation for the sector is extremely important, as the excipients play a major role in high dose formulations and controlled release drugs which are most common in the market now," said Subodh Priolkar, managing director, Colorcon (South Asia). However, there is hardly any move from the government or the industry towards regulating the sector. The adverse reactions reported in other parts of the world due to usage of contaminated excipients show the critical role of excipients in drug manufacturing, he added.

The lack of interest from the Indian side has also slowed down the plans of International Pharmaceutical Excipients Council (IPEC), the flagship organisation of excipients industry worldwide, for launching their Indian chapter offering guidelines for quality manufacturing of excipients. The IPEC chairman David R Schoneker earlier in June 2008 informed Pharmabiz that the council is keen to launch its Indian office. However, neither the drug regulatory body nor the Centre has taken any initiative to invite the council for further discussions, it is learnt. Meanwhile, the council has recently established its operations in China with the support of Chinese government.

"The Indian excipients industry is highly fragmented and there is not a single organisation to represent them. There is a need for an organisation like the pharma manufacturers organisation to bring in changes in the industry including clear cut regulations," averred Prashant Chitgopekar, deputy general manager - Pharma, Dow Chemical International Pvt Ltd.

"There should be an initiative either from the Drug Controller General of India or the pharma associations in this area. Even if the IPEC introduces quality guidelines here, it should be made mandatory by the government so that standards are followed for better results," Priolkar asserted.

The government is likely to bring in regulations on excipients industry as the global regulatory scenario is evolving towards a more intensive regulatory environment. The US Food and Drug Administration is currently in talks with IPEC to implement the regulatory guidelines including good manufacturing practices as mandatory standards. The move will tend Indian excipients industry and the government to introduce regulations in India too, he said.

The Indian excipients industry consists of more than 30 multinational companies and a few hundreds of domestic players. The domestic units are mainly producing commodity excipients like starch and caster oil derivatives while the MNCs are either operating through their own Indian offices or are in tie up with marketing firms supplying the major share of speciality excipients. Data on the size of Indian excipients market, the total number of manufacturers and the issues of these companies are also unrecorded till date, they added.